(123 days)
The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
The Stryker Sorano Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position.
The product consists of a titanium frame (also available in chrome-moly steel), large rear wheels with handrims for propelling the chair, and smaller front pivoting casters for stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.
The Stryker Sorano offers a suspension system made of a fibre glass composite. The two suspension elements are part of the frame construction as they connect the main frame to the rear wheel axle. As it is part of the frame, the suspension is a standard feature.
The Stryker Sorano offers an additional propulsion method to conventional handrims. A lever drive option may be added that provides two forward gear ratios an incorporates a disc braking system. Handrim use is still possible as handrims are standard on all units. The key benefits to the drive system are that it eliminates the need to grip the handrim, provides mechanical advantage and provides an enhanced braking system.
The Stryker Sorano also offers modularity and adjustability features. The seat height, angle, rear seat-to-floor height, and front seat-to-floor height may be adjusted by the end user. The footrest module with caster wheels may be adjusted forward and backward, and the footrest height may be adjusted. The backrest angle and height may also be adjusted. In addition, the footrest module is removable and may be replaced with optional sports or other special purpose footrests. The seat/backrest module and the footrest module may be removed by the user, allowing the entire wheelchair to be packed in a compact space for travel. The optional folding backrest enhances this feature.
The provided text describes the Stryker Sorano Wheelchair, a manual wheelchair, and its FDA 510(k) submission. However, the document does not contain information about a study that proves the device meets specific acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert ground truth).
Instead, the "Performance Data" section states that the device will meet applicable performance standards specified in ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs." This indicates a reliance on an established industry standard for wheelchair performance, rather than a specific, custom-designed study with unique acceptance criteria.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is an attempt to address the request based on the available information, with clear indications of what is not provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with | The Stryker Sorano Wheelchair will meet the applicable performance standards specified in Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs." |
Note: The document states the device will meet these standards, implying a commitment or expectation, rather than reporting specific test results from a study. Actual quantitative performance metrics against these standards are not provided.
Regarding the study proving the device meets acceptance criteria, the document states:
"The Stryker Sorano Wheelchair will meet the applicable performance standards specified in Rehabilitation Engineering Sociey of North American (RESNA) Standard ANSI/ RESNA WC/Vol. 1-1998 'Requirements and Test Methods for Wheelchairs.'"
This indicates that the device's performance is gauged by its adherence to this established industry standard. The document does not describe a specific, custom study conducted by Stryker with unique acceptance criteria and reporting on that study's outcomes. Instead, it leverages existing standards recognized for wheelchair safety and effectiveness.
The following information is NOT available in the provided text:
- 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- No specific test set or data provenance is mentioned beyond the general reference to the RESNA standard.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This is not applicable as no specific test set requiring expert ground truth is described. The performance is assessed against an engineering standard.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable for the same reason as above.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. The device is a mechanical wheelchair, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable. The device is a mechanical wheelchair.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" or standard of performance is defined by the ANSI/RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs." These are engineering and performance specifications, not medical ground truth in the diagnostic sense.
- 8. The sample size for the training set
- This is not applicable. The device is a mechanical wheelchair, not a machine learning model requiring a training set.
- 9. How the ground truth for the training set was established
- This is not applicable for the same reason as above.
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SEP 26 2005
struker
K05/369
Canada
510K Summary: Stryker Sorano Wheelchair
Trade Name: Stryker Sorano
Common Name: Manual Wheelchair
Classification Name: Wheelchair, Mechanical 8911OR
Device Sponsor:
Stryker Canada 45 Innovation Drive Hamilton, ON, Canada L9H 7L8
Regulatory Class: Class I 21 CFR 890.3850 Mechanical Wheelchair
Contact Person:
Kathryn Ronalds, Senior Regulatory Affairs Representative
Predicate Device:
The Stryker Sorano Wheelchair is substantially equivalent to the Invacare Top End Terminator Titanium Manual Wheelchair (K012167, Aug 1/01).
Intended Use:
The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
Device Description:
The Stryker Sorano Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position.
The product consists of a titanium frame (also available in chrome-moly steel), large rear wheels with handrims for propelling the chair, and smaller front pivoting casters for stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.
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The Stryker Sorano offers a suspension system made of a fibre glass composite. The two suspension elements are part of the frame construction as they connect the main frame to the rear wheel axle. As it is part of the frame, the suspension is a standard feature.
The Stryker Sorano offers an additional propulsion method to conventional handrims. A lever drive option may be added that provides two forward gear ratios an incorporates a disc braking system. Handrim use is still possible as handrims are standard on all units. The key benefits to the drive system are that it eliminates the need to grip the handrim, provides mechanical advantage and provides an enhanced braking system.
The Stryker Sorano also offers modularity and adjustability features. The seat height, angle, rear seat-to-floor height, and front seat-to-floor height may be adjusted by the end user. The footrest module with caster wheels may be adjusted forward and backward, and the footrest height may be adjusted. The backrest angle and height may also be adjusted. In addition, the footrest module is removable and may be replaced with optional sports or other special purpose footrests. The seat/backrest module and the footrest module may be removed by the user, allowing the entire wheelchair to be packed in a compact space for travel. The optional folding backrest enhances this feature.
Performance Data:
The Stryker Sorano Wheelchair will meet the applicable performance standards specified in Rehabilitation Engineering Sociey of North American (RESNA) Standard ANSI/ RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs."
Substantial Equivalence (SE) Rational:
The Stryker Sorano Wheelchair is equivalent in intended use, safety, and effectiveness to existing devices being marketed by Invacare.
Safety and Effectiveness:
The Stryker Sorano Wheelchair does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed. Therefore, the Stryker Sorano Wheelchair is substantially equivalent to this existing device.
Signed: Kathryn Ronalds Dated: May, 20 2005
Kathryn Ronalds Senior Regulatory Affairs Representative
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2005
Ms. Sheryl Bagalio Regulatory and Quality Affairs Supervisor Stryker Canada 45 Innovation Drive Hamilton, ON, Canada L9H 7L8
Re: K051369
Trade/Device Name: Stryker Sorano Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 18, 2005 Received: August 19, 2005
Dear Ms. Bagalio:
We have reviewed your Section 510(k) premarket notification of intent to market the device WC nave rowed your be received the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the May 20, 2017 11:11 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic For (10) has the device, subject to the general controls provisions of the Act. The r ou may, diere, eroyisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de rise to such additional controls. Existing major regulations affecting your device can may or sations of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Sheryl Bagalio
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing your antial equivalence of your device to a legally premarket nother device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your as 11-07-20120. Also, please note the regulation entitled, Contact the Office of Compuners and (21 CFR Part 807.97). You may obtain Misolanding by reference to premail.org/w/index.php?title=Pivision of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
| 510K Number: | TBD |
|---|---|
| Device Number: | Stryker Sorano Wheelchair |
| Indications for Use: | The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position. |
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use _ (Part 21 CFR 801.109)
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOS 1369 369
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).